Effects of Hypertonic Saline on the Pulmonary Circulation in Children
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Systemic Vascular Resistance Index
研究概览
简要总结
Pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure in the pulmonary artery, vein, and capillaries. Infusion of hypertonic saline solutions expand the circulating volume, thus allowing more blood to flow and reducing pressure in the artery, vein, and capillaries. Furthermore, infusion of hypertonic saline has been shown to reduce both systemic and pulmonary vascular resistances in adults. If the pulmonary vascular resistance decreases more or to the same degree as the systemic resistance, infusion of hypertonic saline may prove beneficial in the treatment of pulmonary hypertensive crisis. The primary objective of this study is to investigate how a clinically relevant dose of hypertonic saline affects the systemic and pulmonary circulations in children undergoing cardiac catheterization during general anesthesia. This study hypothesizes that an infusion of hypertonic saline over 10 minutes will reduce the pulmonary vascular resistance more than the systemic vascular resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who have had a heart transplant and are scheduled for elective endomyocardial biopsies during general anaesthesia
- •Age > 2 years
排除标准
- •Plasma Na < 130 mmol/l or >150 mmol/l
- •Refusal of consent
- •An estimated pulmonary arterial pressure which is greater than or equal to 66% of systemic blood pressure
- •Children with heart failure (right and/or left), i.e clinical suspicion by either a cardiologist or an anesthesiologist of inability to tolerate a fluid bolus of 3 ml/kg 7.2% NaCl corresponding to an expansion of the circulatory volume by approximately 9% (see the section on safety), which is the equivalent of infusion approximately 20 ml/kg 0.9% NaCl over 10 minutes.
研究组 & 干预措施
3 ml/kg 7.2% NaCl
The test fluids 7.2% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.
干预措施: 7.2% NaCl (Drug)
3 ml/kg 0.9% NaCl
The test fluids 0.9% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.
干预措施: 0.9% NaCl (Drug)
20 ml/kg 0.9% NaCl
The test fluids 0.9% NaCl 20 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.
干预措施: 0.9% NaCl (Drug)
结局指标
主要结局
Systemic Vascular Resistance Index
时间窗: Change from Baseline in Systemic Vascular Resistance Index after 1 hour
Systemic vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.
Cardiac Index
时间窗: Change from Baseline in Cardiac Index after 1 hour
Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization.
Pulmonary Vascular Resistance Index
时间窗: Change from Baseline in Pulmonary Vascular Resistance Index after 1 hour
Pulmonary vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.
次要结局
- Blood Gas(Average over 1 hour)
- Plasma Volume(Average over 1 hour)
- Atrial Natriuretic Peptide(Average over 1 hour)
研究者
Katherine Taylor
Staff Anesthesiologist
The Hospital for Sick Children